Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omnicon Medical Corp. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
50 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823872 | EMERGENCY TRACHEOSTOMY KIT | Omnicon Medical Corp. | 1983-01-21 | 25 | 0 |
| K820577 | ANESTHESIA BACTERIA FILTER | Omnicon Medical Corp. | 1982-03-18 | 15 | 0 |
| K820576 | MAINFLOW BACTERIA FILTER | Omnicon Medical Corp. | 1982-03-18 | 15 | 0 |
| K801803 | MAINFLOW BACTERIA FILTER | Omnicon Medical Corp. | 1980-08-13 | 15 | 0 |
| K801804 | ANESTHESIA BACTERIA FILTER | Omnicon Medical Corp. | 1980-08-13 | 15 | 0 |
| K772060 | PROTECT IV GARD | Omnicon Medical Corp. | 1977-12-20 | 50 | 0 |
| K770136 | DISPOSABLE BACTERIA FILTER | Omnicon Medical Corp. | 1977-02-14 | 21 | 0 |
| K770001 | AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S | Omnicon Medical Corp. | 1977-01-12 | 9 | 0 |
| K760819 | CONDUCTIVE ANESTHESIA BREATHING CIRCUIT | Omnicon Medical Corp. | 1976-10-27 | 15 | 0 |
| K760149 | CONDUCTIVE ANESTHSIA BREATH. CIRCUIT | Omnicon Medical Corp. | 1976-07-19 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda